Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

This study is ongoing, but not recruiting participants.

Sponsor:

Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT00734643

First Posted: August 14, 2008

Last Update Posted: February 13, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors. The specific aims of the study are to describe perceived stress, and coping skills utilized, in parents of children with HLHS and their impact on family outcomes measured as well-being, adaptation and caregiver/family quality of life, and to describe changes in stress, coping, and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation (McCubbin, Thompson, & McCubbin, 1996) is the theoretical framework that guides this research.

Hypotheses:

Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life.

Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes.

Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS.

Mothers and fathers will report different perceptions of stress, coping skills utilized, and family adaptation outcomes during the first 14 months of life with an infant with HLHS.

Further study details as provided by Kathleen Mussatto, Children's Hospital and Health System Foundation, Wisconsin:

Primary Outcome Measures:

Family Adaptation [ Time Frame: 14 months ]

Family adaptation will be measured with the general functioning scale of the Family Assessment Device (FAD) (Miller, Epstein, Bishop & Keitner, 1985) at T1, T2 and T3. The FAD provides an overall measure of family functioning; 12 items, reliability alpha = .83-.86.

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Ages Eligible for Study:

up to 3 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period will be eligible to participate. Parents unable to speak or read English will be excluded. An attempt will be made to obtain consent for participation from both the mother and father of the affected infant. If no father is involved in the care of the infant, measures will be obtained from mothers alone. The model will be tested using mothers' reports of family variables. Single parents will be able to participate but will not be included in comparisons between mothers and fathers. Nurse coordinators at participating centers will conduct subject screening and consenting.

Criteria

Inclusion Criteria:

Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period

Exclusion Criteria:

Parents unable to speak or read English

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734643